Pan -E u ro pe an C lini ca l T ri a ls (E CT ) 30
different rules, the Project Leader estimated that harmonisation was extremely difficult, despite several meetings with the ESF Management Committee. Consequently, problems in some European participating countries delayed regula- tory procedures in Belgium and The Netherlands. The withdrawal of investigators from the UK and Germany had a greater negative impact, since it eliminated six investigating centres. The many stumbling blocks resulted in the UK investiga- tors not being sufficiently motivated to pursue application for the required local procedures. The German investigators did apply to the relevant local regulatory authorities but the issues raised by these authorities and by the German Ethics Committee jeopardised the whole project and finally precluded the participation of Germany in the trial. The PROFIDYS team also faced difficulties in setting up the coordinating sponsor, with a consequent delay in launching the project (effective only in 2007).
Researchers also reported having understood they could count on additional funding from the ESF, which was not the case. The need for the par- ticipants to apply for national funding grants meant further delays generated by several re-evaluations of the protocol by diverse funding institutions, raising various issues and requiring minor protocol amend- ments and an overall destabilising effect on some principal investigators and project coordinators in the rather lengthy period between the initiation of the project and the final approval of the protocol and start of the study.
The Project Leader reported that an improvement of the support to investigators by the institutional environment is clearly needed, especially in the case of the global coordination of such a multicentre, multinational European project, involving a number of different national regulatory authorities.
The ESF would hereby like to:
1. Acknowledge the difficulties described by Professor Philippe Orcel. PROFIDYS illustrates the current difficulties in setting up pan- European Investigator-Driven Clinical Trials (IDCTs), the focus of the ESF-EMRC attention for many years. The EMRC has been strongly advocating the revision of the EU Clinical Trials Directive (EUCTD, 2001/20/EC) since the publication of its Forward Look final report IDCT in March 2009 (http://www.esf.org/ activities/forward-looks/medical-sciences-emrc/ completed-forward-looks-in-medical-sciences/ fl-07-001-investigator-driven-clinical-trials. html) and the publication of the position paper
‘Proposal for a Revision of the “Clinical Trials Directive” (2001/20/EC) and other recommen- dations to facilitate clinical trials’ in December 2011 (http://www.esf.org/research-areas/ medical-sciences/publications.html). These documents identified the important issues that currently hamper clinical trials and worked out proposals on how to facilitate these at the trans- national level.
2. Clarify its role. The ESF’s role is to manage the calls for proposals, the selection of CRPs such as PROFIDYS and the coordination of networking and dissemination activities, but not to relieve the administrative burden related to the (pre-) launch of clinical trials in individual European countries.
3. Clarify the national funding and support issues that arose. Clinical research funding is man- aged at the national level, as there is no ‘common pot’ funding managed by the ESF. Therefore, researchers still have to apply for funding to their national organisations. This is a common misunderstanding shared by many researchers involved in EUROCORES Programmes (not only PROFIDYS). Also, the ESF does not have the power to support to researchers wishing to launch a clinical trial.
4. Express its opinion about the alleged ‘lack of communication’ from the part of the ESF. Several of the last communications from the ESF side pertained to the final report, which was submitted by Professor Orcel to the ESF a year after the official deadline and could thus not be assessed on time by the ECT Review Panel. At the time of writing this report, other final reports of activities that took place in 2011 have still not been submitted to ESF, and the Management Committee has already been made aware of this situation. On the positive side, and as acknowledged by Professor Orcel, “several meetings with the ESF Management Committee” took place, which is unusual for a EUROCORES Programme and shows the ESF involvement and commitment in the (pre-)launch phase. Also, there have been frequent communica-
tions with the PROFIDYS team and its Project Leader through various channels throughout an extended period of time, especially before and during the launch of the clinical trial up to 2007-2008. Dr Carole Moquin-Pattey who coordinated ECT until 2009 even succeeded in getting additional support and funding from the AP-HP. Therefore, the ESF does not fully agree
Pan -E u ro pe an C lini ca l T ri a ls (E CT ) 31
Finally, EMRC would like to add that it welcomes the revision of the European Directive on Clinical Trials and the efforts to convert it into a Regulation, which hopefully will improve harmonisation in the area of clinical trials regulation in Europe. The details of the implementation process are still to be assessed. EMRC has worked for years to improve the situation for investigator- driven clinical trials and is grateful to have been involved in Directorate General SANCO’s consultation process with other academic and industrial stakeholders. EMRC is pleased to see that many areas of concern appear to have been addressed and hope that this regulation will lead to a better situation in the area of IDCTs. The ESF hopes that pan-European clinical trials
Pan -E u ro pe an C lini ca l T ri a ls (E CT )
32 The assessment performed by the Review Panel
was based only on the EURAMOS final report. The PROFIDYS report was submitted way after the deadline established. Out of the nine members of the Review Panel, five members contributed to this assessment: Patrick Bossuyt (NL), Tamas Doczi (HU), Outi Hovatta (SE), Luc Van Bortel (BE) and Magi Farre (ES).
In this final evaluation by the Review Panel, EURAMOS was quantitatively and qualitatively assessed on the basis of the following criteria: 1. Progress of the CRP: achievement of goals, inte-
gration of teams’ outputs
2. Programme integration of both CRPs (EUR AMOS and PROFIDYS) into the EUROCORES Programme objectives
3. Networking, training and dissemination activi- ties